A commitment to life

Transcription

1 A commitment to life

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3 We are, each and every one of us, Kyowa Kirin For several years, ProStrakan has been a member of Kyowa Kirin, a Japan-based Pharmaceutical company. As part of its commitment to become a global pharmaceutical specialty organisation, Kyowa Kirin is harmonising all its affiliates across the globe, and from April 2016, ProStrakan became known as Kyowa Kirin. Kyowa Kirin aims to contribute to the health and comfort of people around the world. Our mission is to respond to the needs of patients suffering from diseases for which no effective treatments are available, their families and the healthcare professionals fighting those diseases on the front line. 3

4 A company with qualities like no other Specialising in the core fields of oncology, nephrology, immunology / allergy and the central nervous system, we develop leading-edge biotechnologies, focussing on the use of antibodies, to develop and discover innovative new drugs, which Kyowa Kirin market worldwide. Biotechnology is our greatest strength, driving sustained growth. We will maintain our leading-edge in this field, continue to innovate and emphasise our passion for science. Our business model allows us to combine the strengths of each company in the group and respond to changes in the external environment. As a global company, we must earn the trust of society by excelling in our social responsibilities. We work to maintain transparency, fairness, compliance and co-existence with our local communities. 4

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6 We want to be known as a company that cares for quality of life Our vision is to be a global specialty pharmaceutical company, contributing to human health and wellbeing worldwide through innovative drug discovery and global commercialisation. This work will be driven by leading-edge antibody technologies in the core therapeutic areas of oncology, nephrology, immunology/allergy and the central nervous system. We are currently focussing on launching pipeline products originated by Kyowa Kirin in Europe and the United States. 6

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8 Taking the walk of life one life at a time Our values are the foundation of our success and are reflected in the strength and dedication demonstrated by our team every day. We inspire and challenge our people to think creatively and work together to create a better world and help people live healthier, more fulfilling lives. We cultivate a strong culture and provide a working environment that promotes collaboration, innovation, respect, diversity, teamwork and ethics. Our respect for life, health and wellness inspires everything we do. These are our values: Believe in ourselves Find strength in numbers Celebrate and take pride in our shared mission Strive to be fearlessly innovative Accelerate our efforts Pursue our objectives with honesty and integrity Support wellness and quality of life 8

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10 History we can be proud of With expertise based on a history of innovation, Kyowa Kirin and ProStrakan have worked together to contribute to the health and wellbeing of people around the world by creating new value through the pursuit of advances in life sciences and technologies Strakan founded. Strakan and ProSkelia merge to form ProStrakan. ProStrakan acquires OTL Pharma (Paris) and Elfar and Devon Farmacéutica (Spain). ProStrakan floats on the London Stock Exchange. ProStrakan acquires APS Pharma (Germany) Kyowa Kirin completes one of Japan s leading facilities for producing investigational therapeutic antibodies at the Bio Process Research and Development Laboratories as well as new research buildings in the Tokyo Research Park. ProStrakan acquired by Kyowa Kirin. Kyowa Kirin constructs a new facility for formulation of solid dosage forms at the Ube Plant. 10

11 ProStrakan collaborates with Novartis (bone) and Amgen (renal). ProStrakan sells Drug Discovery Unit (formerly ProSkelia). ProStrakan announces a collaboration in the United States with NovaQuest and a Nordic sales joint venture with Orexo AB. Kyowa Hakko Kirin (Kyowa Kirin) was formed through the merger of Kyowa Hakko and Kirin Pharma ProStrakan completes acquisition of Archimedes. Kyowa Kirin completes construction of Drug Product Manufacturing Facility in the Takasaki Plant. Kyowa Kirin completes the construction of a new research building at the Fuji Research Park. ProStrakan rebrands as Kyowa Kirin. 11

12 Be proud of your work, the work to save precious lives Through growth, evolution and acquisition we are well on our way to becoming a truly global specialty pharmaceutical company, enabling us to market a range of products in Europe and the United States. Some of our specialist therapy areas in Europe and the United States are outlined below. Oncology and supportive care Oncology is one of Kyowa Kirin s core therapeutic areas. In Europe and the United States we provide a large range of supportive care products which aim to improve patient quality of life. Our portfolio includes chemotherapy and oestrogen agonist /antagonist products to help prevent disease progression, as well as supportive oncology medicines that help relieve breakthrough cancer pain. We also provide products that treat the side effects of cancer treatments, such as antiemetics to reduce patient suffering from chemotherapy-induced nausea and vomiting. Novel supplementary and supportive medicines We have a long and successful history with bone health and micronutrient deficiency treatment. We are continually developing our products and expanding our ranges to ensure the needs and preferences of patients are met. We hope to address deficiencies affecting patient health, as well as help patients receiving specific therapy for osteoporosis, to protect their bones. We strive to make novel therapies available to ensure patients receive the most appropriate treatment options. Please note that not all products are available in every European country and / or the United States for all therapeutic areas listed above. However, through an extensive partnership network we actively seek to make our products available across the globe. 12

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14 Infinite possibilities Building on our strengths, we will follow category-based strategies in our core therapeutic areas, while using our worldwide network to become a global specialty pharmaceutical company. A global network Expanding our global business platform from drug discovery to development and marketing. Kyowa Kirin s drug discovery network around the world is integrated. We are expanding marketing channels in the United States and Europe. Therapeutic antibody Using cutting-edge biotechnology. Kyowa Kirin uses its core proprietary technology, POTELLIGENT, in strategic alliances with other companies in order to rapidly expand its antibody business. 14

15 Product development Kyowa Kirin is executing a category-based strategy in the therapeutic areas of nephrology, oncology, immunology/allergy and the central nervous system. We encourage collaboration between research and development, manufacturing and sales, which accelerates new discoveries, drives development, and maximises product value. A solid management foundation Creating an organisation and corporate culture appropriate for a global specialty pharmaceutical company. Our relationships with shareholders, investors and partners are based on fairness and transparency. We seek to fulfil our social responsibilities and create a culture in which our people can grow. 15

16 Amazing results when we become one To achieve our vision of becoming a global specialty pharmaceutical company, Kyowa Kirin is expanding our business operations worldwide, from drug discovery to development and marketing. 4 San Diego In Europe, the United States and Asia, we are expanding our business operations in accordance with business strategies tailored to each country and region. Clinical development network Kyowa Kirin has an extensive clinical development network spanning Europe, the United States and Asia to ensure that pipeline products are developed and launched on a global scale. In every step of the process, we exploit our technology and know-how. Step one: Drug discovery research We will pursue new research possibilities into genes, proteins and other substances at the molecular level for the development of new drugs based on new mechanisms. Step four: Clinical development At Kyowa Kirin s development centres in Europe, the United States and Asia, we undertake clinical quality assurance to evaluate the efficacy and safety of pharmaceuticals in accordance with the standards of each country. Step two: Screening and optimisation Using synthetic chemistry and biotechnology we explore hidden potential, allowing us to develop new ideas from diverse perspectives. Step five: Production and quality assurance To ensure our products meet global quality standards, the four Kyowa Kirin plants in Japan feature the latest technology and equipment, and employ a quality assurance system which rigorously checks every step in the manufacturing process, from drug substance to drug products. Step three: Pre-clinical research By evaluating new ideas from every angle, from their effectiveness to their safety as a medicinal drug, we aim to create valuable, high-potential pharmaceuticals. Step six: Sales and marketing A local presence in major markets provides high-quality sales and marketing support. 16

17 13 branches not pictured on the map Japan Singapore Our global locations: North America and Europe 1 Kyowa Kirin USA Holdings, Inc. 1 2 Kyowa Kirin Pharmaceutical Development, Inc. 3 BioWa, Inc. 2 4 Kyowa Kirin Pharmaceutical Research, Inc. 5 Kyowa Kirin International plc. 6 Kyowa Kirin Pharma S.A.S. 7 Kyowa Kirin Farmacéutica, S.L.U. 8 Kyowa Kirin GmbH. 9 Kyowa Kirin Pharma B.V. 10 Kyowa Kirin S.r.l. 11 Kyowa Kirin AB. 12 Kyowa Kirin, Inc. Asia 13 Kyowa Hakko Kirin China Pharmaceutical Co., Ltd. 14 Kyowa Hakko Kirin Korea Co., Ltd. 15 Kyowa Hakko Kirin (Taiwan) Co., Ltd. 16 Kyowa Hakko Kirin (Hong Kong) Co., Ltd. 17 Kyowa Hakko Kirin (Singapore) Pte. Ltd. / Singapore Translational Research Laboratory 18 Kyowa Hakko Kirin (Thailand) Co., Ltd. Japan 19 Head Office 20 Tokyo Research Park 21 Takasaki Plant 22 Bio Process Research and Development Laboratories 23 Fuji Plant 24 CMC Research and Development Center 25 Fuji Research Park 26 Ube Plant 1. United States holding company. 2. Licensing of therapeutic antibodies and alliance activities intended to acquire promising external innovations and technologies. 17

18 Innovation is not just about growth, but a leap towards the future A core strength of Kyowa Kirin, therapeutic antibodies are designed to use the immune system to treat diseases. We are establishing proprietary antibody technologies to move our business forward with strategic alliances, as well as for our own new drug development. Developing POTELLIGENT technology into an antibody business To maximise the value of the therapeutic antibodies in our pipeline, we are taking multiple approaches to development, including out-licensing candidates at early stages and concluding antibody technology licensing contracts with other companies. Having multiple approaches allows us to accelerate the commercialisation of therapeutic antibodies to develop a world-class business, while providing new drugs for diseases that do not yet have effective treatments. We are moving forward with recently concluded product-level development alliance agreements for the humanised antibody KW-0761 that was created using our POTELLIGENT technology. This product is gaining attention as a potential cancer immunotherapy, which is a treatment designed to harness and enhance the innate powers of the immune system to fight cancer. KW-0761 is a strategic product for us in becoming a global specialty pharmaceutical company. We have concluded an agreement with AstraZeneca in the United Kingdom, Pfizer and Bristol-Myers Squibb in the United States and Ono Pharmaceutical in Japan to study its possible efficacy as an immunotherapy for solid tumours. 18

19 POTELLIGENT Antibody-dependent cellular cytotoxicity (ADCC) 1 enables more effective elimination of target cells. Antibody A key feature of POTELLIGENT, a proprietary Kyowa Kirin technology, is its ability to increase ADCC activity by reducing the amount of fucose in the sugar chain of antibodies. Testing has shown that POTELLIGENT dramatically enhances effectiveness in attacking cancer cells and other targets compared to conventional therapeutic antibodies. Fucose 1. An immune response that mobilises natural killer cells, monocytes, and other leukocytes to destroy cancer cells and other target cells tagged with antibodies. 1. There is a sugar chain in the lower part of antibodies. 2. A sugar residue called fucose is found on the sugar chain of normal antibodies. 3. POTELLIGENT technology enhances ADCC activity by reducing fucose. 19

20 Countless precious lives surround us Kyowa Kirin s patented therapeutic antibody technology enables efficient, high-quality production using advanced manufacturing equipment. We actively conduct research leading to new and improved production and formulation technologies for our products. This innovative approach allows us to deliver consistently good value to our customers. KRN23 KRN23 is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone fibroblast growth factor 23, known as FGF23. Human Antibody-Producing Technology As this technology has enabled us to generate fully human antibodies with the same diversity as naturally produced human antibodies, we have opened up new opportunities for clinical application. FGF23 is a hormone that reduces serum levels of phosphorus and vitamin D by regulating phosphate excretion and vitamin D production by the kidney. XLH is a disorder of phosphate metabolism caused by phosphate wasting in the urine leading to severe hypophosphatemia. XLH is the most common heritable form of rickets (the softening and weakening of bones) that is inherited as an X-linked dominant trait affecting both males and females, though some reports indicate that the disease may be more severe in males. 20

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22 Believe in what we have built together Promising pharmaceutical candidates are emerging from our development pipelines the result of our never-ending efforts to hone our state-of-the-art technologies and deliver innovation in medical care. Research and Development pipeline. All data current at 22 January Key: Antibody Protein Small molecule New molecular entity Filed /approved Phase II and Phase III ONCOLOGY NEPHROLOGY KRN321 Darbepoetin Alfa Injection MOA: Long-Acting Erythropoiesis Stimulating Agent Therapy area: Renal Anemia (on Dialysis) Stage: Filed in CN Licensed from: Kirin-Amgen Granisetron Patch MOA: 5-HT 3 Serotonin Receptor Antagonist Therapy area: Chemotherapy induced nausea and vomiting Stage: Filed in MY Licensed from: Solasia Pharma (ProStrakan) Remarks: Already launched in US and EU RTA 402 Bardoxolone Methyl Oral MOA: Antioxidant Inflammation Modulator Therapy area: CKD in patients with Type 2 Diabetes Stage: Phase II in JP Licensed from: Reata KW-0761 Mogamulizumab Injection MOA: Anti-CCR4 Humanised Antibody Therapy area: Adult T-cell Leukemia / Lymphoma Stage: Phase II in US, EU and others Therapy area: Cutaneous T-cell Lymphoma Stage: Phase III in US, EU, JP and others Developed: In-House Remarks: POTELLIGENT IMMUNOLOGY/ALLERGY KHK4827 Brodalumab Injection MOA: Anti-IL-17 Receptor Fully Human Antibody Therapy area: Psoriasis Stage: Filed in JP Licensed from: Kirin-Amgen KHK4563 Benralizumab Injection MOA: Anti-IL-5 Receptor Humanised Antibody Therapy area: Asthma Stage: Phase III in JP and KR Therapy area: Chronic Obstructive Pulmonary Disease (COPD) Stage: Phase III in JP Developed: In-House Remarks: POTELLIGENT. Jointly developed with AstraZeneca / MedImmune in JP and KR CENTRAL NERVOUS SYSTEM KW-6002 Istradefylline Oral MOA: Adenosine A 2A Receptor Antagonist Therapy area: Parkinson s Disease Stage: Phase III in US, CA, EU and others Developed: In-House OTHER AMG531 Romiplostim Injection MOA: Thrombopoietin Receptor Agonist Therapy area: Idiopathic (Immune) Thrombocytopenic Purpura Stage: Filed in TH, MY Licensed from: Kirin-Amgen KRN23 Injection MOA: Anti-FGF23 Fully Human Antibody Therapy area: X-linked Hypophosphatemia (XLH) in adult patients Stage: Phase III in US, CA, EU, JP and KR Therapy area: X-linked Hypophosphatemia (XLH) in pediatric patients Stage: Phase II in US and EU Therapy area: Tumor Induced Osteomalacia (TIO) / Epidermal Nevus Syndrome (ENS) Stage: Phase II in US Developed: In-House Remarks: Jointly developed with Ultragenyx in US and EU 22

23 KHK7580 Oral MOA: Calcium Receptor Agonist Therapy area: Secondary Hyperparathyroidism Stage: Phase III in Japan Licensed from: Mitsubishi Tanabe Pharma ARQ 197 Tivantinib Oral MOA: c-met Inhibitor Therapy area: Hepatocellular Cancer Stage: Phase III in JP Licensed from: ArQule BIW-8962 Injection MOA: Anti-GM2 Humanised Antibody Therapy area: Cancer Stage: Phase I/IIa in KR Developed: In-House Remarks: POTELLIGENT ASKP1240 Injection MOA: Anti-CD40 Fully Human Antibody Therapy area: Organ Transplant Rejection Stage: Phase I in JP, Phase II in US Developed: In-House Remarks: Jointly developed with Astellas Z-206 Mesalazine Oral MOA: ph Dependent Controlled Release Tablet Therapy area: Ulcerative Colitis Stage: Phase III in JP Licensed from: Zeria Pharma Remarks: Jointly developed with Zeria Pharma AMG531 Romiplostim Injection MOA: Thrombopoietin Receptor Agonist Therapy area: Aplastic Anemia Stage: Phase II in KR Therapy area: Idiopathic (Immune) Thrombocytopenic Purpura Stage: Phase III in CN Licensed from: Kirin-Amgen 23

24 Don t just make medicine, make people smile We aim to be a trusted global specialty pharmaceutical company and are building the necessary robust foundations by ensuring global compliance and by executing a Corporate Social Responsibility (CSR) programme that meets the expectations of society. Management philosophy and CSR In our group management philosophy, we promise to contribute to the health and wellbeing of people around the world by creating new value through the pursuit of advances in life sciences and technologies. We consider it part of our CSR to realise our management philosophy through activities consistent with these guidelines. Business partners We promote fair transactions, partnering and CSR procurement to become a global specialty pharmaceutical company. Environment We make efforts to be environmentally responsible, including reducing our CO 2 emissions and promote activities which support the achievement of a sustainable society. Society and community We want to earn the trust of society and the community, and are dedicated to activities that contribute to both, making use of the assets we have acquired through our businesses. Employees We respect the human rights and individuality of our people, and seek to be a company that not only promotes diversity, but grows along with them. 24

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26 Our team, our company Our business is global in vision and scale. We are working in close collaboration with our group companies in the pharmaceutical and biochemical industries to bring exciting new products to markets around the world. For all enquiries in the Republic of Ireland please contact: Kyowa Kirin International plc. Galabank Business Park Galashiels Selkirkshire TD1 1QH Tel: +44 (0) Web: Main Group companies Europe Kyowa Kirin International plc Galabank Business Park Galashiels TD1 1QH United Kingdom Tel: +44 (0) United States Kyowa Kirin, Inc. 135 Route 202/206, Suite 6 Bedminster NJ Tel: Code: GEN/IRE/0001(1) Date of preparation: April 2016 This brochure is printed using 100% mineral oil-free inks, on FSC certified papers. Brochure design by weareglidden.com 26

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